Gall Bladder Cancer
Conditions
Brief summary
The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting. The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.
Detailed description
Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.
Interventions
PROCEDURERobotic-assisted radical cholecystectomy
Procedure will be performed robotic-assisted
PROCEDUREOpen radical cholecystectomy
Procedure will be open
Sponsors
University Hospital, Linkoeping
Sahlgrenska University Hospital
Rigshospitalet, Denmark
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference. * Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.
Exclusion criteria
* Previous extensive surgery in the upper abdomen (for example open liver surgery) * Pregnancy * Intraoperative findings of dissemination (patient is then excluded after randomization) * Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization). * Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to functional recovery | Days from operation | As defined as: 1. has adequate pain control with oral analgesics only (NRS\<5) 2. is independently mobile at the preoperative level 3. is able to maintain sufficient oral caloric intake (minimum of 50% required calories) 4. has no need for intravenous fluid administration 5. has no clinical signs of infection or infection treated with peroral antibiotics only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Days | Time from operation until hospital discharge (days) |
| Post-operative complications | Within 90 days from surgery | Classified according to Clavien-Dindo |
| Number of retrieved lymph nodes | Within 6 weeks after surgery | As reported by pathologists |
| Total cost | 1 year | Direct and indirect cost measured in euros |
| Abdominal wall complaints | 1 year | Using the ventral hernia pain questionnaire |
| Quality of life of patients | 1 year | Using quality of life formulaire EORTC QLQ-C30 |
Countries
Sweden
Contacts
Primary ContactChristian Sturesson, PhD
Outcome results
None listed